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Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT) (CONCERT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03881852
Recruitment Status : Completed
First Posted : March 20, 2019
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE March 15, 2019
First Posted Date  ICMJE March 20, 2019
Last Update Posted Date January 14, 2020
Actual Study Start Date  ICMJE January 30, 2019
Actual Primary Completion Date November 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
Number of cataplexy attacks [ Time Frame: Change from Baseline to end of Week 2 (Period 1) and Week 5 (Period 2) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03881852 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
  • Epworth Sleepiness Scale (ESS) [ Time Frame: Change from Baseline to end of Week 2 (Period 1) and Week 5 (Period 2) ]
    The ESS is a patient-reported questionnaire consisting 8 questions. Each of the items are rated on a 4-point scale (0-3), based on the usual chances of dozing off or falling asleep while engaged in eight different activities. The total ESS score can range from 0 to 24.
  • Maintenance of Wakefulness Test (MWT) [ Time Frame: Change from Baseline to end of Week 2 (Period 1) and Week 5 (Period 2) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)
Official Title  ICMJE A Multi-center, Randomized, Double-blind, Placebo-controlled, 3-Week Crossover Study to Assess the Efficacy and Safety of AXS-12 in Subjects With Cataplexy and Excessive Daytime Sleepiness in Narcolepsy
Brief Summary CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment) is a Phase 2, double-blind, randomized, placebo-controlled, crossover, multicenter trial of AXS-12 in patients with narcolepsy. The study will enroll approximately 20 patients, all of whom will be treated with AXS-12 for three weeks, and with placebo for three weeks. Eligible patients will be randomized to receive either AXS-12 followed by placebo, or placebo followed by AXS-12. Efficacy assessments will include the frequency of cataplexy attacks, and measures of other symptoms of narcolepsy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Narcolepsy
  • Cataplexy Narcolepsy
  • Excessive Sleepiness
Intervention  ICMJE
  • Drug: AXS-12 (Reboxetine)
    Dosed orally, twice daily for up to 3 weeks
  • Drug: Placebo
    Dosed orally, twice daily for up to 3 weeks
Study Arms  ICMJE
  • Experimental: AXS-12 (reboxetine)
    Intervention: Drug: AXS-12 (Reboxetine)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2020)
21
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2019)
20
Actual Study Completion Date  ICMJE November 27, 2019
Actual Primary Completion Date November 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Male or female subjects between 18 and 70 years of age, inclusive
  • Primary diagnosis of narcolepsy with cataplexy
  • Willing and able to comply with the study requirements

Exclusion Criteria:

  • Other clinically significant conditions potentially causing EDS
  • Clinically significant psychiatric disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03881852
Other Study ID Numbers  ICMJE AXS-12-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Axsome Therapeutics, Inc.
Study Sponsor  ICMJE Axsome Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Axsome Therapeutics, Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP